Wound Closure Devices and System

ABSTRACT

Methods and devices are provided for closing a puncture wound. In one exemplary embodiment, a puncture closure device is provided having an elongate tubular body that is disposable through a puncture in tissue and that includes proximal and distal portions. The proximal portion can be adapted to expand to form proximal wings upon rotation of the elongate tubular body, preferably in a first direction. The distal portion can be adapted to expand to form distal wings upon rotation of the elongate tubular body, preferably in a second, opposite direction. The proximal and distal portions can also be adapted to be moved toward one another as they expand upon rotation. As a result, the proximal and distal wings can engage tissue therebetween.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is continuation of U.S. application Ser. No. 12/558,842filed Sep. 14, 2009, and entitled “Wound Closure Methods,” which is adivisional of U.S. application Ser. No. 11/307,372 (now U.S. Pat. No.7,625,392) filed Feb. 3, 2006, and entitled “Wound Closure Devices andMethods,” each of which is hereby incorporated by reference in itsentirety.

FIELD OF THE INVENTION

The present invention relates to methods and devices for closing avascular puncture wound.

BACKGROUND OF THE INVENTION

Catheterization and interventional procedures, such as angioplasty orstenting, generally are performed by inserting a hollow needle through apatient's skin and intervening tissue into the vascular system. Aguidewire may then be passed through the needle lumen into the patient'sblood vessel accessed by the needle. The needle may be removed, and theintroducer sheath may be advanced over the guidewire into the vessele.g. in conjunction with or subsequent to a dilator. A catheter or otherdevice may then be advanced through a lumen of the introducer sheath andover the guidewire into a position for performing a medical procedure.Thus, the introducer sheath may facilitate introducing various devicesinto the vessel, while minimizing trauma to the vessel wall and/orminimizing blood loss during a procedure.

Upon completing the procedure, the devices and introducer sheath may beremoved, leaving a puncture site in the vessel wall. External pressuremay be applied to the puncture site until clotting and wound sealingoccur. This procedure however, may be time consuming and expensiverequiring as much as an hour of a physician or assistant's time. It isalso uncomfortable for the patient and requires that the patient remainimmobilized in the operating room, catheter lab, or holding area. Inaddition a risk of a hematoma exists from bleeding before hemostasisoccurs.

Various apparatus have been suggested for percutaneously sealing avascular puncture by introducer sheath into a puncture site. Whendeployed, the plug seals the vessel and provides hemostasis. Such plugs,however, may be difficult to position properly with respect to thevessel. Moreover, it is generally undesirable to expose the pluggedmaterial, e.g. collagen, to the blood stream where it may float downstream and risk causing an embolism. Another technique involvespercutaneously suturing the puncture site. Percutaneous suturingdevices, however, may require significant skills by the user and may bemechanical complex and expensive to manufacture.

Other closure devices include surgical fasteners. One known surgicalfastener includes an annular base having legs that, in a relaxed state,extend in a direction substantially perpendicular to a plane defined bythe base and slightly inwards toward one another. During use, thefastener is fit around the outside of a cannula, thereby deflecting thelegs outward. The cannula is placed in an incision, and the fastener isslid along the cannula until the legs pierce into the blood vessel. Whenthe cannula is withdrawn, the legs move towards one another and back tothe relaxed state to close the incision. Staples can also be used toclose a wound or incision. Staples, however, tend to have a largecross-sectional profile and therefore may not be easy to deliver througha percutaneous site to close an opening in a vessel wall.

Accordingly, improved methods and devices for closing a vascularpuncture wound are needed.

SUMMARY OF THE INVENTION

The present invention generally provides methods and devices for closinga puncture wound. In one exemplary embodiment, a puncture closure deviceis provided having an elongate tubular body that is disposable through apuncture in tissue and that includes proximal and distal portions. Theproximal portion can be adapted to expand to form proximal wings uponrotation of part of the elongate tubular body, preferably in a firstdirection. The distal portion can be adapted to expand to form distalwings upon rotation of part of the elongate tubular body, preferably ina second, opposite direction. The proximal and distal portions can alsobe adapted to be moved toward one another as they expand upon rotation.As a result, the proximal and distal wings can engage tissuetherebetween.

While the proximal and distal portions can have a variety ofconfigurations, in one exemplary embodiment the proximal and distalportions can each include a plurality of slits formed therein andconfigured to allow portions of the elongate tubular body surroundingthe plurality of slits to expand to form the proximal and distal wings.In an exemplary embodiment, the slits in the proximal portion extend ina first direction around a circumference of the elongate tubular body,and the slits in the distal portion extend in a second oppositedirection around the circumference of the elongate tubular body. Inanother embodiment, the proximal wings can extend in a plane that issubstantially parallel to a plane in which the distal wings extend. Theproximal and distal wings can also be spaced a distance apart from oneanother to allow tissue to be engaged therebetween.

The device can also include an elongate shaft extending through andattached to a distal end of the elongate tubular body. In an exemplaryembodiment, the elongate shaft can include a frangible portionconfigured to allow at least a proximal portion of the elongate shaft tobe broken away from a distal portion of the elongate shaft or from theelongate tubular body. The device can also include an actuator coupledto the elongate tubular body and adapted to rotate at least a portion ofthe elongate tubular body. In certain exemplary embodiments, theactuator can be removably coupled to a proximal end of the elongatetubular body. In another exemplary embodiment, the elongate tubular bodycan be formed from a deformable material and/or a resorbable material.

A system for closing a puncture in tissue is also provided and includesan elongate tubular body having proximal and distal portions with aplurality of slits formed therein. The elongate tubular body can beadapted to extend outwardly between each of the plurality of slitsformed in the proximal and distal portions such that the proximal anddistal portions are adapted to engage tissue therebetween. The elongatetubular body can also include a mid-portion formed between the proximaland distal portions and adapted to be positioned within a puncture holeformed in tissue engaged between the proximal and distal portions. Inone exemplary embodiment, the slits in the proximal portion can extendin a first direction around a circumference of the elongate tubularbody, and the slits in the distal portion can extend in a secondopposite direction around the circumference of the elongate tubularbody. The proximal portion can thus be adapted to extend outwardly whenrotated in a first direction, and the distal portion can be adapted toextend outwardly when rotated in a second opposite direction. Theelongate tubular body can also include an elongate shaft extendingtherethrough and attached to a distal end thereof. The elongate shaftcan include a frangible portion configured to allow at least a proximalportion of the elongate shaft to be broken away from a distal portion ofthe elongate shaft.

The system can further include an actuator removably coupled to theelongate tubular body and adapted to apply an axial and rotational forceto the elongate tubular body to cause the elongate tubular body toextend outwardly. In one exemplary embodiment, the actuator includes anouter shaft that is removably coupled to a proximal end of the elongatetubular body. The outer shaft can include, for example, a protrusionformed therein and adapted to extend into a corresponding groove formedon the proximal end of the elongate tubular body for removably couplingthe outer shaft to the elongate tubular body. The actuator can alsoinclude an elongate shaft that extends through and couples to a distalend of the elongate tubular body. The outer shaft can be rotatablydisposed around the elongate shaft to allow the outer shaft to applyaxial and rotational forces to the elongate tubular body.

A method for closing a puncture in tissue is also provided and in oneexemplary embodiment the method can include inserting an elongatetubular body through a puncture in tissue, for example by inserting thebody through an introducer sheath that guides the elongate tubular bodythrough tissue. The sheath can optionally be predisposed within thepuncture. The proximal and distal portions of the elongate tubular bodycan then be rotated to expand the proximal and distal portions such thattissue surrounding the puncture is engaged between the expanded proximaland distal portions thereby sealing the puncture. In an exemplaryembodiment, prior to rotating the body, the proximal and distal portionsof the elongate tubular body are positioned through the puncture on afirst side of the tissue. The body can be rotated by, for example,rotating and expanding the distal portion, retracting the elongatetubular body until the expanded distal portion engages tissue, androtating and expanding the proximal portion. The distal portion ispreferably rotated and expanded before rotating and expanding theproximal portion of the elongate tubular body. The proximal and distalportions can also optionally be compressed as they are expanded androtated. For example, the proximal and distal portions can be advancedin a distal direction while rotating the proximal and distal portions.In an exemplary embodiment, proximal and distal portions are rotatedusing an actuator. The actuator can include an outer shaft that isrotated in a first direction to rotate and expand the distal portion ofthe elongate tubular body, and that is rotated in a second oppositedirection to rotate and expand the proximal portion of the elongatetubular body. Preferably, the outer shaft is rotated relative to anelongate shaft that is coupled to a distal end of the elongate tubularbody. The elongate shaft can optionally be broken away from the elongatetubular body once the body is implanted. This can be achieved, forexample, by rotating the elongate shaft. In other embodiments, insertingthe elongate tubular body can include guiding the elongate tubular bodyalong a guidewire predisposed within a lumen containing the puncture,and/or viewing blood flashback from a lumen containing the puncture toconfirm that the elongate tubular body has passed through the puncture.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention will be more fully understood from the following detaileddescription taken in conjunction with the accompanying drawings, inwhich:

FIG. 1A is a perspective view of one exemplary embodiment of a closuredevice in an initial, unformed configuration;

FIG. 1B is a cross-sectional view of the closure device of FIG. 1A priorto deployment;

FIG. 1C is an end view of the closure device of FIG. 1A followingdeployment of the distal wings;

FIG. 1D is an end view of the closure device of FIG. 1A followingdeployment of the proximal wings;

FIG. 2A is a perspective view of one exemplary embodiment of an actuatorfor deploying a closure device, showing the closure device of FIG. 1Acoupled thereto;

FIG. 2B is a cross-sectional view of the closure device of FIG. 1A andan inner shaft of the actuator of FIG. 2A;

FIG. 2C is a cross-sectional view of another embodiment of the closuredevice of FIG. 1A and an inner shaft of the actuator of FIG. 2A;

FIG. 2D is a perspective view of a portion of a former tube of theactuator of FIG. 2A coupled to the closure device of FIG. 1A;

FIG. 2E is a cross-sectional view of another embodiment of a former tubefor use with the actuator device of FIG. 2A;

FIG. 2F is a cross-sectional view of yet another embodiment of a formertube for use with the actuator device of FIG. 2A;

a sequence of steps for deploying the closure device to close a puncturein the wall of an artery;

FIG. 3A is a cross-sectional view of the closure device of FIG. 1A and aportion of the actuator of FIG. 2A, showing the closure device deployedto close a puncture wound in the wall of an artery;

FIG. 3B is a cross-sectional view of the closure device and a portion ofthe actuator of FIG. 3A following retraction of a former tube of theactuator;

FIG. 3C is a cross-sectional view of the closure device and portion ofthe actuator of FIG. 4B, following detachment of an inner shaft of theactuator;

FIG. 4A is a cross-sectional view of the handle portion of the actuatorof FIG. 2A;

FIG. 4B is a perspective view of a proximal portion of the actuator ofFIG. 4A in an initial, starting position;

FIG. 4C is a perspective view of the proximal portion of the actuatorshown in FIG. 4B following deployment of the distal wings of a closuredevice;

FIG. 4D is a perspective view of the proximal portion of the actuatorshown in FIG. 4CB following deployment of the proximal wings;

FIG. 5 is a partially cross-sectional view of one embodiment of accesssheath disposed a femoral artery;

FIG. 6 is a partially cross-sectional view of the access sheath of FIG.5 having a closure device and actuator positioned therethrough;

FIG. 7 is a partially cross-sectional view of the access sheath, closuredevice, and actuator of FIG. 6 with the closure device disposed withinthe femoral artery;

FIG. 8A is a partially cross-sectional view of the closure device ofFIG. 7 following deployment of the distal wings;

FIG. 8B is a perspective view of the actuator of FIG. 7 followingdeployment of the distal wings;

FIG. 9 is a partially cross-sectional view of the closure device of FIG.8A retracted to engage the puncture hole;

FIG. 10A is a partially cross-sectional view of the closure device ofFIG. 9 with the proximal wings deployed to engage the puncture holebetween the proximal and distal wings; and

FIG. 10B is a perspective view of the actuator of FIG. 8B following fulldeployment of the proximal wings of the closure device.

DETAILED DESCRIPTION OF THE INVENTION

Certain exemplary embodiments will now be described to provide anoverall understanding of the principles of the structure, function,manufacture, and use of the devices and methods disclosed herein. One ormore examples of these embodiments are illustrated in the accompanyingdrawings. Those of ordinary skill in the art will understand that thedevices and methods specifically described herein and illustrated in theaccompanying drawings are non-limiting exemplary embodiments and thatthe scope of the present invention is defined solely by the claims. Thefeatures illustrated or described in connection with one exemplaryembodiment may be combined with the features of other embodiments. Suchmodifications and variations are intended to be included within thescope of the present invention.

The present invention provides methods and devices for closing apuncture wound in tissue. In general, the closure device can be in theform of an elongate body that is adapted to be positioned within apuncture, and that includes proximal and distal portions that areconfigured to radially expand to engage tissue therebetween and therebyclose the puncture. FIG. 1A illustrates one exemplary embodiment of sucha closure device 10. The device 10 is illustrated in an initial,un-deployed configuration, and as shown the device 10 is in the form ofa generally elongate tubular body 12 with a closed or sealed distal end10 b and an open proximal end 10 a. The tubular body 12 can be formedfrom a variety of materials. In an exemplary embodiment, the closuredevice is formed from a deformable material that undergoes plasticdeformation (i.e. deformation with negligible elastic component).Exemplary materials include, by way of non-limiting example, anybiocompatible and/or bioabsorbable materials, including, for example,titanium (and titanium alloys), magnesium alloys, stainless steel,polymeric materials (synthetic and/or natural), ceramic, etc. Materialswhich are not normally radiopaque e.g. Magnesium Alloy, may be enhancedand made x-ray visible with the addition of x-ray visible materials,such as particles of Iron Oxide, stainless steel, titanium, tantalum,platinum or any other suitable equivalents. The elongate tubular body 12can also be manufactured using various techniques. For example, the body12 can be formed from a piece of tubing, or it can be formed from sheetstock material. The developed surface of the final tubular shape may bestamped and folded into position. Various joining processes such aswelding, soldering, etc. may be used to join any seams.

As indicated above, the device 10 can include one or more portions thatexpand to engage tissue therebetween and thereby close a puncture. Inthe embodiment shown in FIG. 1A, the device includes proximal and distalportions 12 a, 12 b that are configured to expand to engage tissuetherebetween. While various techniques can be used to allow the proximaland distal portions 12 a, 12 b to expand, in an exemplary embodiment theproximal and distal portions 12 a, 12 b each include a plurality ofslits 14 a, 14 b formed therein and configured to allow portions of theelongate tubular body 12 between the plurality of slits 14 a, 14 b toradially expand, as will be discussed below. A mid-portion 13 of thetubular body 12, located between the proximal and distal portions 12 a,12 b, can be non-expanding and may vary in length. The mid-portion 13 isconfigured to be positioned within a puncture hole, and thus it can havea length that corresponds to a thickness of the tissue wall.Alternatively, the mid-portion 13 can be configured to expand outward.Openings in the form of holes and slots may be located in the wall ofthe elongate body 12 at the mid-portion 13.

The slits 14 a, 14 b in the proximal and distal portions 12 a, 12 b canextend in any direction and each portion 12 a, 12 b can include anynumber of slits. Preferably the slits 14 a, 14 b are configured suchthat certain portions of the elongate tubular body 12 between the slitswill extend outward away from a central axis A of the tubular body 12when the body 12 is axially compressed, and preferably rotated as well.As a result, one or more wings will form in each of the proximal anddistal portions 12 a, 12 b to engage tissue therebetween. In anexemplary embodiment, as shown in FIG. 1A, the slits 14 a, 14 b in theproximal and distal portions 12 a, 12 b are curved and extend transverseto a central axis A of the elongate tubular body 12 such that they atleast partially extend around the elongate tubular body 12. Morepreferably, the slits 14 a in the proximal portion 12 a extend in afirst direction around a circumference of the elongate tubular body 12and the slits 14 b in the distal portion 12 b extend in a secondopposite direction around the circumference of the elongate tubular body12. Such a configuration allows the tubular body 12 to be rotated in afirst direction to cause only one of the proximal and distal portions 12a, 12 b to radially expand, and then to be rotated in a second directionto cause the other one of the proximal and distal portions 12 a, 12 b toradially expand. A person skilled in the art will appreciate that theslits 14 a, 14 b can have a variety of other shapes and sizes, and thatthey can extend in various directions, such as helical or parallel tothe central axis A of the tubular body. The slits 14 a, 14 b can alsoinclude additional curved slits extending from each end of the mainslits 14 a, 14 b to ensure that the end profile of the wings is alignedclose to the main body 12 of the closure device 10 following deployment.This can help to ensure a fluid tight seal. These curved end slits canalso narrow the width of the tubing section between slits thusencouraging the wings to bend outward at this point.

FIGS. 1B-1C show distal end views of the closure device 10 in itspre-deployed configuration, following partial deployment, and followingfull deployment, respectively. In the pre-deployed configuration, asshown in FIG. 1B, the elongate tubular body 12 has a diameter that isconfigured to fit within a puncture hole in a vessel, and that is alsopreferably configured to fit within an introducer sheath for guiding thedevice 10 to a puncture site, as will be discussed in more detail below.FIG. 1C illustrates the distal portion 12 b radially expanded to formdistal wings 16 b, and FIG. 1D illustrates the proximal portion 12 aradially expanded to form proximal wings 16 a. The wings 16 a, 16 b areformed by the material between the slits 14 a, 14 b, which is deformedoutward as the elongate tubular body 12 is compressed and preferablyrotated. In the illustrated embodiment, the slits 14 a, 14 b areconfigured such that the proximal and distal portions 12 a, 12 b eachinclude three wings 16 a, 16 b, however the proximal and distal portions12 a, 12 b can include any number of wings 16 a, 16 b. The size andshape of the wings 16 a, 16 b can also vary depending on the locationand length of the slits 14 a, 14 b. In an exemplary embodiment, the sizeand shape of the wings 16 a, 16 b is maximized to maximize the contactarea between the wings 16 a, 16 b and the tissue surrounding thepuncture hole within which the device 10 is deployed. As shown in FIGS.1C and 1D, the wings 16 a, 16 b are substantially ovular and have agenerally planar configuration such that the wings 16 a, 16 b extendsubstantially parallel to one another. The proximal and distal wings 16a, 16 b can also be configured to be offset from one another, as shownin FIG. 1D, to further maximize the contact area around the puncturehole. The proximal and distal wings 16 a, 16 b are also preferablyconfigured to be positioned a distance apart from one another. Thelength of the mid-portion 13 is determinative of the distance betweenthe wings 16 a, 16 b.

The wings 16 a, 16 b and/or other portions of the closure device 10 canalso optionally include extensions or protrusions which are configuredto puncture the engaged tissue. For example, each wing 16 a, 16 b caninclude one or more tissue-penetrating protrusions formed thereon. Theextensions or protrusions can better facilitate anchoring of the closuredevice 10 at a puncture site, and they can also be used to facilitateclosure of the puncture. During deployment, as will be discussed in moredetail below, the extensions or protrusions can puncture the tissuearound the puncture wound, and upon rotation of the wings 16 a, 16 bwill twist this tissue in a spiral motion causing it to compress aroundthe puncture and seal the hole.

As indicated above, the wings 16 a, 16 b on the closure device 10 can beformed by compressing and preferably rotating the closure device 10.While various techniques can be used to deploy and actuate the closuredevice 10, in one exemplary embodiment the closure device 10 isremovably coupled to an actuator that is adapted to apply an axial androtational force to the elongate tubular body 12 to cause the elongatetubular body 12 to extend outwardly. FIGS. 2A illustrates one exemplaryembodiment of an actuator 20 for deploying the closure device 10. Ingeneral, the actuator 20 includes a proximal portion in the form of ahandle 22, and an elongate shaft extending distally from the handle 22and having a distal end that is removably coupled to the closure device10. The elongate shaft preferably includes an outer shaft 24, hereafterreferred to as a former 24, that is effective to apply axial and/orrotational forces to the closure device 10, and an inner shaft 26 (shownin FIGS. 2B and 2C) that mates to the closure device 10 and that iseffective to hold a portion of the closure device 10 in a fixed positionwhile axial and/or rotational forces are being applied to the closuredevice 10 to allow the closure device 10 to be deformed, as will bediscussed in more detail below. While not shown, the actuator 20 canalso include an over sleeve that is attached to the former 24 at itsdistal end. The sleeve can help prevent separation of the closure device10 from the actuator 20.

The inner shaft 26 can be coupled to the closure device 10 at a varietyof locations and using a variety of techniques. In an exemplaryembodiment, the inner shaft 26 is removably coupled to the closuredevice 10, and more preferably it is frangibly coupled to the closuredevice 10 to allow at least a portion of the inner shaft 26 to bedetached and separated from the closure device 10 after the device isdeployed. FIG. 2B illustrates one exemplary embodiment of an inner shaft26 that is frangibly coupled to the closure device 10 at a frangibleportion 28. As shown, the inner shaft 26 extends through the closuredevice 10 and attaches to the closed distal end 10 b of the closuredevice 10. An adhesive or any other mating technique can be used toattach the distal end of the inner shaft 26 to the distal end 10 b ofthe closure device 10. The frangible portion 28 of the shaft 26 isconfigured such that it will break when a force is applied thereto. Thefrangible portion 28 can be formed at any location on the shaft 26, forexample, the distal-most end of the shaft 26 can be configured to breakaway from the distal end 10 b of the closure device 10. Alternatively,as shown in FIG. 2B, the frangible portion 28 can be located a distanceaway from the distal end 10 b of the closure device 10, such that aportion of the inner shaft 26 will remain attached to the closure device10, and the remainder of the inner shaft 26 can be separated from theclosure device 10. The frangible portion 28 can be formed using varioustechniques known in the art. For example, the inner shaft 26 can includea thinned or weakened region. This can be achieved by reducing theamount of material at that region, or by scoring or otherwise removingsome of the material used to form the inner shaft 26. In use, thefrangible portion 28 can be broken by applying a force, such as arotational or axial force, to the inner shaft 26. In other embodiments,the inner shaft 26 can be attached to the closure device 10 using athreaded attachment. During use, the inner shaft 26 can be rotatedrelative to the closure device 10 so as to unscrew the inner shaft 26from the closure device 10. Once detached, the inner shaft 26 is removedfrom the patient leaving the closure device 10 in position at thepuncture site. A person skilled in the art will appreciate that avariety of mating techniques can be used, including, for example, aninterference fit, a mechanical interlock, etc.

In another embodiment, as shown in FIG. 2C, the inner shaft 26′ caninclude a reduced diameter region 27′ formed distal of the frangibleportion 28′. The reduced diameter region 27′ is preferably configured tobe aligned with the mid-portion 13′ of the closure device 10′ when theclosure device 10′ is fully deployed. As further shown in FIG. 2C, theclosure device 10′ can include one or more holes or openings 11′ formedin the sidewalls thereof at the mid-portion 13′ of the device 10′. Inuse, the reduced diameter region 27′ will be positioned within thepuncture wound adjacent to the holes 11′. This will allow blood to enterthrough the holes 11′ to initiate tissue growth, during and followingresorption of the closure device 10′.

As previously indicated, the actuator 20 also includes an outer shaft orformer 24 that is disposed around the inner shaft 26 and that iseffective to apply axially and/or rotational forces to the closuredevice 10 to deploy the closure device 10. The former 24 can have avariety of configurations, but it is preferably adapted to couple to aproximal end 10 a of the closure device 10. While various techniques canbe used to couple to the closure device 10, FIG. 2D illustrates oneexemplary technique. As shown, the former 24 includes one or moreprotrusions 24 a that extend into one or more complementary grooves orcut-outs 15 formed in the proximal end of the closure device 10.

The former 24 can also be configured to provide maximum flexibilityduring clinical use. While the former 24 can merely be formed form aflexible material, in other embodiments the former 24 can include one ormore flexible regions formed thereon. FIGS. 2E and 2F show exemplaryembodiments of flexible regions. In the embodiment shown in FIG. 2E, thetube includes an interrupted slotted pattern 30. In the embodiment shownin FIG. 2F, the tube includes a spiral slit or interrupted spiral slit32 cut through the wall of the tube. Such configurations provideflexibility along the length of the former, but can also ensure that anaxial and/or rotational force applied to one end of the former will betransmitted along the length of the former to the other end.

FIGS. 3A-3B illustrate a distal portion of the former 24 and inner shaft26 of the actuator 20 in use with the closure device 10 positionedwithin a puncture wound and fully deployed to close the puncture. InFIG. 3A, the protrusions 24 a on the former 24 are positioned within thecorresponding cut-outs 15 formed in the proximal end of the closuredevice 10, such that the former 24 is mated to the closure device 10.The former 24 can thus be rotated relative to the inner shaft 26, tothereby rotate the proximal and distal portions of the closure device 10to form proximal and distal wings that engage tissue therebetween, asshown. Following deployment of the closure device 10, the actuator mustbe disconnected and removed from the patient. FIG. 3B illustrates theformer 24 retracted relative to the closure device 10 in order to exposethe frangible portion 28 formed on the inner shaft 26. Once exposed, aforce can be applied to the inner shaft 26 to break the frangibleportion 28, and thereby separate the proximal portion of the shaft 26from the distal portion of the shaft, which remains coupled to theclosure device 10, as shown in FIG. 3C.

In order to effect rotation of the former tube 24 relative to the innershaft 26, the handle 22 of the actuator 20 can optionally include anactuation mechanism formed thereon. In an exemplary embodiment, as shownin FIGS. 4A-4D, the handle 22 includes an outer collar 36 rotatablydisposed therearound and having guide tracks 38 formed therein. Theouter collar 36 can be coupled to proximal portion of the former 24 suchthat rotation of the collar 36 is effective to rotate the former 24. Theproximal end of the inner shaft 26 can also include an inner collar 37that is attached to the inner shaft 26, and that includes pin 40 formedthereon or extending therefrom. The pin 40 extends through and ispositioned within the guide tracks 38. Since the position of the pin 40is fixed due to the inner shaft 26 being fixed, movement of the outercollar 36, and thus the former 24, is governed by the configuration ofthe guide tracks 38 which can move relative to the fixed pin 40. As aresult, the guide tracks 38 can be used to control the axial androtational forces applied to the closure device 10 coupled to the distalend of the former 24.

As shown in FIGS. 4B-4D, the guide tracks 38 can have a configurationthat allows the collar 36 to rotate in a first direction, e.g., counterclockwise, to deploy the distal wings of the closure device. Inparticular, as the outer collar 36 is rotated counter clockwise, theformer tube 24 will rotate in a counter-clockwise direction, therebyrotating the proximal end of the closure device 10 to expand the distalwings of the closure device. As previously discussed, since the slits inthe proximal and distal portions preferably extend in oppositiondirections, rotation of the closure device in a first direction willonly deploy the distal wings. Once the outer collar 36 is fully rotated,the guide tracks 38 can allow distal movement of the outer collar 36,while the guide pin 40 remains in a fixed position at all times, thusallowing the outer collar 36 to be advanced distally. As a result, theformer tube 24 will apply compressive forces on the closure device,thereby causing the distal wings to collapse into a substantially planarconfiguration.

The guide tracks 38 can then allow the outer collar 36 to rotate in anopposite direction, e.g., a clockwise direction, to cause the formertube 24 to rotate clockwise. As the former tube 24 rotates clockwise,the proximal wings will expand. Once the outer collar 36 is fullyrotated, the guide tracks 38 can allow distal movement of the outercollar 36 therein, thus allowing the outer collar 36 to be advanceddistally. As a result, the former tube 24 will apply compressive forceson the closure device, thereby causing the proximal wings to collapseinto a substantially planar configuration. The guide tracks 38 caninclude a track portion that allows the outer collar 36 to be movedproximally, as shown in FIG. 4C, to allow the former 24 to be retractedrelative to the closure device 10, thereby exposing the frangibleportion on the inner shaft.

A person skilled in the art will appreciate that the guide tracks 38 canhave a variety of other configurations. For example, rather thanallowing rotation, and then distal movement, the guide tracks 38 canextend at an angle around the handle 22 to allow rotational andcompressive forces to be simultaneously applied to the closure device. Aperson skill in the art will appreciate that a variety of othertechniques can be used to actuate the former 24 to deploy the closuredevice.

The present invention also provides exemplary methods for closing apuncture wound. While various devices can be used to effect the method,FIGS. 5-9 illustrate an exemplary method for closing a puncture woundusing the closure device 10 of FIG. 1A and the actuator 20 of FIG. 2A.During therapeutic or diagnostic procedures, an access sheath iscommonly placed within the vessel, e.g., the femoral artery, tofacilitate delivery of catheters into the vascular system. The accesssheath 50, as illustrated in FIG. 5, typically includes a hub 52 at itsproximal end incorporating a valve to prevent blood leakage. However,the valve can be configured to facilitate entry of components into thesheath 50 and onward into the puncture wound or vasculature. Prior todelivery of the closure device, the access sheath 50 is advanced fullyinto the puncture wound P until the hub 52 is in contact with thepatient's skin. The former 24 of the actuator 20 is then advancedthrough the access sheath hub 52 and onward through the sheath 50, asshown in FIG. 6. In an exemplary embodiment, the former tube 24 caninclude a marker formed thereon that can be aligned with the proximalmost end of the hub 52 on the access sheath 50 so as to retain theclosure device 10 within the access sheath 50 and thereby prevent traumato the wall of the vessel. While holding the actuator in position, theaccess sheath 50 can be pulled back along the former 24 until itcontacts the handle 22 on the actuator 20, as shown in FIG. 7. Theclosure device 10 is now exposed within the lumen of the vessel and isready for deployment.

Alternatively, a side hole may be positioned in the wall of the closuredevice 10 or in the wall at the distal end of the former tube 24. Thishole can open into a tubular channel leading to the actuator handle 22.As the actuator 20 is advanced through the sheath 50, the side hole isnot in contact with blood flow. Once the closure device 10 and/or thedistal end of the former 24 exits the sheath 50 into the femoral artery,blood will enter the side hole and advance through the channel to exitat the actuator handle 22. This will signal to the user that the closuredevice 10 is now in the blood lumen, and no further advancing isrequired and the device 10 is ready for deployment.

In other embodiments, the device 10 may be delivered to the artery lumenover a guidewire. The proximal end of the guidewire, which extends fromthe patient, can be inserted into an opening at the distal tip of theclosure device 10. It can extend through the shaft and handle 22 of theactuator 20, or in other embodiments it can exit through a side holelocated either in the closure device 10 or at the distal end of theformer tube 24.

Once the closure device 10 is positioned to be deployed, the outercollar 36 on the handle 22 of the actuator 20 can be rotated in a first,e.g., counter-clockwise as shown in FIG. 8B, to cause the distal portionof the closure device 10 to expand away from the central axis. Acompressive force can simultaneously or subsequently be applied to theclosure device 10 to cause the expanded portions of the closure device10 to collapse, and thereby form distal wings 16 b, as shown in FIG. 8A.

Following deployment of the distal wings 16 b, the actuator 20 andaccess sheath 50 can be retracted from the patient until tension is feltindicating the correct position of the distal wings 16 b at the internalsurface of the puncture site, as shown in FIG. 9. The proximal wings cannow be deployed in order to complete the closure of the puncture hole P.This is achieved by rotating the actuator outer collar 36 in an oppositedirection, e.g., a clockwise direction, as shown in FIG. 10B. This inturn causes the former tube 24 to rotate the proximal end of the closuredevice 10 in a clockwise direction causing the proximal portion of theclosure device 10 to expand outward. The former tube 24 can besimultaneously or subsequently advanced distally causing the expandedportions of the closure device 10 to collapse and form proximal wings 16a, as shown in FIG. 10A. As a result, the proximal and distal wings 16a, 16 b engage the tissue surrounding the puncture P therebetween. Theclosure device 10 is now completely deployed and the puncture hole Psealed. The actuator 20 can be removed as previously discussed.

One skilled in the art will appreciate further features and advantagesof the invention based on the above-described embodiments. Accordingly,the invention is not to be limited by what has been particularly shownand described, except as indicated by the appended claims. Allpublications and references cited herein are expressly incorporatedherein by reference in their entirety.

1. A puncture closure device, comprising: an elongate tubular bodyhaving proximal and distal portions and a mid-portion disposedtherebetween, the elongate tubular body being movable between an initialconfiguration and a first position in which rotation of the distalportion relative to the mid-portion expands the distal portion to formdistal wings, and the elongate body being movable between the firstposition and a second position in which rotation of the proximal portionrelative to the mid-portion expands the proximal portion to formproximal wings, and wherein the proximal and distal wings are configuredto engage tissue therebetween.
 2. The puncture closure device of claim1, wherein rotation of the first position is in an opposite direction ofrotation of the second position.
 3. The puncture closure device of claim1, further comprising a plug disposed in the elongate tubular body. 4.The device of claim 1, further comprising: a plurality of distal slitsformed in the distal portion, the distal slits being configured to allowportions of the elongate tubular body surrounding the plurality ofdistal slits to expand to form the distal wings; and a plurality ofproximal slits formed in the proximal portion, the proximal slits beingconfigured to allow portions of the elongate tubular body surroundingthe plurality of proximal slits to expand to form the proximal wings. 5.The device of claim 4, wherein the plurality of distal slits extend in afirst direction around a circumference of the elongate tubular body andthe plurality of proximal slits extend in a second, opposite directionaround the circumference of the elongate tubular body.
 6. The device ofclaim 4, wherein the plurality of distal slits and the plurality ofproximal slits are curved.
 7. The device of claim 1, further comprisingan elongate shaft extending through and attached to a distal end of theelongate tubular body.
 8. The device of claim 7, wherein the elongateshaft comprises a frangible portion configured to allow at least aproximal portion of the elongate shaft to be broken away from a distalportion of the elongate shaft.
 9. The device of claim 8, wherein thefrangible portion is configured to occlude a lumen extending through theelongate tubular body.
 10. The device of claim 7, wherein the elongateshaft is configured to form the distal wings and the proximal wings byinitiating the rotation of the distal and proximal portions from asingle location.
 11. The device of claim 1, wherein the distal wingsextend in a plane that is substantially parallel to a plane in which thedistal wings extend.
 12. The device of claim 1, wherein the distal andproximal wings are spaced a distance apart from one another.
 13. Thedevice of claim 1, wherein the distal and proximal wings are configuredto be formed by a combination of compression of the elongate tubularbody and rotation of the elongate tubular body.
 14. The device of claim13, wherein the elongate tubular body is movable to form the distal andproximal wings such that rotation to form one of the distal and proximalwings occurs prior to compression to form the one of the distal andproximal wings.
 15. A system for closing a puncture in tissue,comprising: a puncture closure device having an elongate tubular bodywith proximal and distal portions, the distal portion being configuredto expand to form distal wings and the proximal portion being configuredto expand to form proximal wings, whereby the proximal and distal wingsare adapted to engage tissue therebetween; and an actuator removablycoupled to a proximal end of the puncture closure device, the actuatorbeing rotatable in a first direction to cause the distal portion toexpand to form the distal wings and being rotatable in a second,opposite direction to cause the proximal portion to expand to form theproximal wings.
 16. The system of claim 15, wherein the actuator furthercomprises guide tracks configured to allow the actuator to rotate andcompress the elongate tubular body of the puncture closure device toform one of the distal and proximal wings.
 17. The system of claim 16,wherein the guide tracks are configured such that a rotational force isapplied to the elongate tubular body to form one of the distal andproximal wings prior to applying a compression force to the elongatetubular body to form the one of the distal and proximal wings.
 18. Thesystem of claim 15, wherein the actuator includes an elongate shaftextending therethrough and attached to a distal end of the elongatetubular body.
 19. The system of claim 18, wherein the elongate shaftincludes a frangible portion configured to allow at least a proximalportion of the elongate shaft to be broken away from a distal portion ofthe elongate shaft.
 20. The system of claim 19, wherein the frangibleportion is configured to occlude a lumen extending through the elongatetubular body.
 21. The device of claim 15, wherein the actuator isconfigured to form the distal wings and the proximal wings by initiatingrotation of the distal and proximal portions from a single location. 22.The system of claim 15, wherein the puncture closure device furthercomprises: a plurality of distal slits formed in the distal portion ofthe elongate tubular body, the distal slits being configured to allowportions of the elongate tubular body surrounding the plurality ofdistal slits to expand to form the distal wings; and a plurality ofproximal slits formed in the proximal portion of the elongate tubularbody, the proximal slits being configured to allow portions of theelongate tubular body surrounding the plurality of proximal slits toexpand to form the proximal wings.
 23. The device of claim 22, whereinthe plurality of distal slits extend in a first direction around acircumference of the elongate tubular body and the plurality of proximalslits extend in a second, opposite direction around the circumference ofthe elongate tubular body.